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In May 2012 the Centers for Medicare & Medicaid Services published its Final Rule revising the hospital and critical access hospital Conditions of Participation (“CoPs”). The Final Rule is intended to reduce outmoded or unnecessarily burdensome rules and thereby increase the ability of hospitals and critical access hospitals to devote their resources to providing high quality patient care.

AORN submitted comments to CMS in December 2011 in response to its proposed rule changes in this area. AORN’s comments supported the intent of the rule changes and also advocated for CMS to better reflect the importance of nursing in this and future rule-makings by the agency. AORN also recommended that CMS consider addressing evaluation of continued competency as an element to assure clinical staff performance and improvement in future rule-makings.

AORN is pleased to see many of the proposed changes AORN supported have been finalized in the May 16 Final Rule. Following is a summary of the changes.

Governing Body Requirements. CMS proposed to allow a single governing body for hospitals in multi-hospital systems. AORN supported this change and agreed that integrated governance can enhance efficiency and consistency in care. AORN believes this move has the potential to streamline workflow for nurses who implement the policies approved by their hospital’s governing body. In the Final Rule, CMS approved this revision and also added an additional requirement that at least one member of a hospital’s medical staff serve as a member of the multi-hospital system governing body in order to ensure communication and coordination between the system’s governing body and the medical staffs of the individual hospitals.

Patient’s Rights Requirements. CMS proposed to modify the reporting requirements when a patient death involves only the use of two-point wrist restraints and no use of seclusion. AORN supported this change because it would reduce unnecessary regulatory burdens for perioperative nurses providing care in the post-anesthesia care unit without negatively impacting patient safety. CMS finalized this proposed rule with minimal change, clarifying that hospitals need only to record in an internal log or other system soft wrist restraint-related deaths, and need not submit the information in the log to CMS or otherwise publicly release the information.

Medical Staff. CMS proposed to clarify that a hospital may grant privileges to both physicians and non-physicians to practice within their state scope of practice, regardless of whether they are also appointed to the medical staff. AORN was pleased to see guidance in the proposed rule from CMS intended to ease regulatory confusion for registered nurses, APRNs, and other non-physician clinicians seeking hospital privileges. AORN’s comments to CMS on this proposal highlighted the role of the RNFA and expressed support for the change because it would ease confusion and reduce unnecessary restrictions on legal, safe care of patients by appropriately educated and trained registered nurses. In the Final Rule, CMS removed the proposed concept of physicians and other clinicians being privileged to practice without appointment to the medical staff. Under the Final Rule, the medical staff may include other categories of non-physician clinicians. While the Final Rule falls short of requiring hospitals to place APRNs and other clinicians on the medical staff, the rule and its accompanying narrative does signal that CMS is supportive of APRNs, PAs and other clinicians practicing to the full extent of their scope under state law.

Nursing Care Plan. CMS proposed to integrate the nursing care plan into the overall interdisciplinary care plan in those hospitals that use an interdisciplinary plan of care. AORN supported this proposal because it would reduce the paperwork burden on nursing staff and allow more time for nurses to provide direct patient care. The Final Rule permits either a stand-alone nursing care plan or one integrated into an interdisciplinary care plan.

Administration of Medications. The Final Rule allows hospitals to have an optional program for patients and support persons for self-administration of appropriate medications. The program must address the safe and accurate administration of specified medications, ensure a process for medication security, address self-administration training and supervision, and document medication self-administration. AORN supported this patient-centered proposal because it allows patients much-needed ability to control aspects of their care and offers a cost-effective way to manage care in a more responsive and direct manner.

Administration of blood transfusions and intravenous medications. The Final Rule eliminates the requirement for non-physician personnel to have special training in administering blood transfusions and intravenous medications. CMS also revised the requirement to clarify that those who administer blood transfusions and intravenous medications do so in accordance with state law and approved medical staff policies and procedures. AORN supported this proposal and agreed that training and education in blood transfusions is standard practice for many providers, including perioperative nurses who work in the operating room setting. AORN shared its belief with CMS that the person administering blood transfusions and IV medication should always be a registered nurse, APRN, physician or physician assistant.

Orders by Other Practitioners. CMS proposed to allow all clinicians acting in accordance with state law and hospital privileges to provide orders for drugs and biologicals. AORN supported this change as consistent with the IOM Future of Nursing report and believes it will speed access to direct quality care for many patients nationwide. The Final Rule allows for drugs and biologicals to be prepared and administered on the orders of non-physician practitioners provided such practitioners are acting pursuant to state law, hospital policy, and medical staff bylaws, rules and regulations. The non-physician practitioners may also document and sign these orders pursuant to state law and hospital policy.

Standing Orders. The Final Rule allows hospitals flexibility to use standing orders but adds a requirement for medical staff, nursing and pharmacy to approve written and electronic standing orders, order sets, and protocols. The rule also requires that orders and protocols be based on nationally recognized and evidence-based guidelines and recommendations. AORN supported this change because approved standing orders and surgeon preference sheets help eliminate delays in patient care before, during and after surgery. AORN was also pleased to see the requirement that the review process for standing orders and protocols include consultation with nursing and pharmacy leadership. Not only is this requirement consistent with the IOM Future of Nursing recommendations that nursing be included in leadership roles, it will be a valuable change for all patients having invasive procedures. AORN believes many patient care delays and mistakes can be avoided when nursing is involved in the initial decision-making process on hospital policies and patient care directives.

Verbal Orders. The Final Rule eliminates the requirement for authentication of verbal orders within 48 hours and instead defers to applicable state law for authentication timeframes. AORN applauded this change because the 48-hour rule had proved impractical, with limited efficacy and effect, and imposed a significant and substantial burden for the ordering practitioner as well as the hospital, and particularly the nursing staff that is often charged with the responsibility of ensuring the ordering practitioner carries out the authentication requirement.

Infection Control Log. The Final Rule eliminates the obsolete requirement for a hospital to maintain an infection control log. Hospitals are already required to monitor infections and do so through various surveillance methods including electronic systems. AORN supported this change because it will reduce compliance burdens.

Outpatient Services Director. The Final Rule removes the requirement for a single director of outpatient services position, as many hospitals already have separate directors for individual outpatient departments and the single, overall director position may be duplicative and unnecessary. AORN supported this change because it will reduce compliance burdens.

Transplant Center Process Requirements. The Final Rule eliminates a duplicative requirement for an organ recovery team that is working for the transplant center to conduct a blood type and other vital data verification before organ recovery when the recipient is known, as the verification will continue to be completed at two other times in the transplant process. AORN supported this change because it will eliminate some of the administrative burden on perioperative nurses providing care in the operating room.

The regulations outlined in the Final Rule will be effective June 16, 2012. For more information from CMS on this and other hospital regulations, please visit the CMS website.